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Probing the Cannabinoid System in Individuals With a Family History of Psychosis

This study is currently recruiting participants.
Verified June 2017 by Mohini Ranganathan, Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02102113
First Posted: April 2, 2014
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
  Purpose
The overall purpose of this study is to determine whether a family history of psychosis is associated with an altered cannabinoid system. This will be tested by studying individuals with and without a family history of psychosis and comparing their responses to delta 9-tetrahydrocannabinol (THC), a probe of the cannabinoid system. We hypothesize, that compared to controls with no family history of psychoses, individuals with a family history of psychoses will have an altered response to THC.

Condition Intervention
Psychosis Cannabis Use THC Marijuana Schizophrenia Drug: Placebo Drug: Very Low Dose THC Drug: Low Dose THC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Probing the Cannabinoid System in Individuals With a Family History of Psychosis

Resource links provided by NLM:


Further study details as provided by Mohini Ranganathan, Yale University:

Primary Outcome Measures:
  • Positive and Negative Symptom Scale for Schizophrenia (PANSS) [ Time Frame: -30 min from administration of THC ]
    Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.

  • Positive and Negative Symptom Scale for Schizophrenia (PANSS) [ Time Frame: +80 min from administration of THC ]
    Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.

  • Positive and Negative Symptom Scale for Schizophrenia (PANSS) [ Time Frame: +150 min of administration of THC ]
    Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.

  • Positive and Negative Symptom Scale for Schizophrenia (PANSS) [ Time Frame: +240 min of administration of THC ]
    Positive, negative and general symptoms will be assessed using the positive, negative and general symptoms subscales of the PANSS.


Secondary Outcome Measures:
  • Clinician Administered Dissociative Symptoms Scale (CADSS) [ Time Frame: -30 min, +15 min, +80 min, +150 min, +240 min ]
    Perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-report items and 8 clinician-rated items (0=not at all, 4=extremely). The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.

  • Visual Analog Scale (VAS) [ Time Frame: -30 min, +15 min, +80 min, +150 min, +240 min ]
    Feeling states associated with cannabis intoxication will be measured using a self-reported visual analogue scale of four feeling states ("high", "anxious", "calm and relaxed", and "tired") associated with cannabis effects. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11 mm line (0=not at all, 100=extremely). These data will be captured to validate that the experiment is relevant to cannabis effects.

  • Hopkins Verbal Learning Test (HVLT) [ Time Frame: +50 min ]
    The HVLT is a 12 word list that is semantically organized. The task consists of 5 trials, an interference list, and free delayed recall and recognition. A different version of the AVLT will be administered on each test day and counterbalanced across subjects.

  • Psychotomimetic States Inventory (PSI) [ Time Frame: -30 min, +240 min ]
    The PSI is a measure of drug induced psychotomimetic states. This self-report scale consists of 28 items rated 0 (not at all) to 3 (extremely) and will facilitate the characterization of a wide range of dissociative/hallucinatory phenomena as well as cognitive disorganization associated with the administration of THC.


Estimated Enrollment: 72
Study Start Date: January 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Family History of Psychosis (FHN)
Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.
Drug: Placebo
placebo
Drug: Very Low Dose THC
Subjects will receive 0.010mg/kg.
Other Name: delta 9-tetrahydrocannabinol
Drug: Low Dose THC
Subjects will receive 0.018 mg/kg over 20 minutes.
Other Name: delta 9-tetrahydrocannabinol
Experimental: Family History of Psychosis (FHP)
Individuals with a family member with a confirmed diagnosis of psychosis. They will receive the placebo, very low dose THC, and low dose THC interventions.
Drug: Placebo
placebo
Drug: Very Low Dose THC
Subjects will receive 0.010mg/kg.
Other Name: delta 9-tetrahydrocannabinol
Drug: Low Dose THC
Subjects will receive 0.018 mg/kg over 20 minutes.
Other Name: delta 9-tetrahydrocannabinol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria FHP:

  • Exposure to cannabis at least once in their lifetime
  • Medically and psychiatrically healthy based on screening
  • Having one relative with a confirmed psychotic disorder

Exclusion Criteria FHP:

  • Current or lifetime major DSM-IV Axis I disorder
  • Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
  • Major or unstable medical illness that might impact safety of the subject in the study
  • Cannabis naive
  • IQ less than 85
  • Less than a high school diploma or its educational equivalent
  • Pregnancy or lactation
  • Major current or recent (<6 weeks) psychosocial stressors.

Inclusion Criteria FHN :

  • Exposure to cannabis at least once in their lifetime
  • Medically and psychiatrically healthy based on screening

Exclusion Criteria FHN:

  • Having a family member with psychosis
  • Current or lifetime major DSM-IV Axis I disorder
  • Current or lifetime treatment (at least 6 months) with psychotropic medications for major psychiatric or neurological illness
  • Major or unstable medical illness that might impact safety of the subject in the study
  • Cannabis naive
  • IQ less than 85
  • Less than a high school diploma or its educational equivalent
  • Pregnancy or lactation
  • Major current or recent (<6 weeks) psychosocial stressors.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102113


Contacts
Contact: Christina Luddy, BS 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Christina Luddy, BS    203-932-5711 ext 4549    christina.luddy@yale.edu   
Principal Investigator: Mohini Ranganathan, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mohini Ranganathan, MD Yale University
  More Information

Responsible Party: Mohini Ranganathan, Assistant Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02102113     History of Changes
Other Study ID Numbers: 1310012948
First Submitted: March 26, 2014
First Posted: April 2, 2014
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists